Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC
Inclusion Criteria:
1. Patients who have provided written informed consent
2. Patients who have urothelial cell carcinoma of the bladder with clinically apparent
stage Ta, grade G1-G2 and satisfy both of the following criteria:
- The maximum number of tumors is 5.
- Each tumor diameter: ≤ 3.5 cm.
3. Age: ≥20 years old at enrollment.
4. The functions of the major organs are adequate, and the following test value criteria
are satisfied:
- Neutrophil count ≥1,500/μL
- Platelet count ≥10×10^4/μL
- Hemoglobin ≥10 g/dL
Exclusion Criteria:
1. Patients with a single, primary bladder cancer of <0.5 cm.
2. Patients with CIS lesions in the bladder or a history thereof.
3. Patients with a history of other than stage Ta, histological grade G1 or G2 disease.
4. Patients experiencing recurrence within 4 months following TURBT for prior NMIBC
(duration between the last TURBT and cystoscopic confirmation of the present
recurrence is within 4 months).
5. Patients without at least a three-month cystoscopically confirmed recurrence-free
interval between the last TURBT and the time of study screening
6. Patients having a bladder tumor with a histological diagnosis other than urothelial
carcinoma of the bladder or a history thereof.
7. Patients who had been administered EO9 in the past.
8. Patients who had been administered any other investigational drug within the past 30
days.
9. Patients having a medical condition that would make it unsafe for them to undergo
TURBT under general or spinal anesthesia.